TBLM

Clinical Study “Common” Name (formal title)	Study design	Treatment arms	Primary outcomes	Results	Author conclusions	“Real-world” impact
GENEVA (Global Evaluation of ImplaNtable DExamethasone in Retinal Vein Occlusion with Macular EdemA)	Randomized, prospective, multicenter, masked, sham-controlled, parallel-group phase 3 trials *NOTE: For the open-label phase, starting 6 months after the initial treatment, the 0.7 mg implant was administered if needed to all patients in any arms. [Haller.2011] Patients were then followed for an additional 6 months, for a total of 12 months. [Haller. 2011] A total of 997 study eyes received a DEX implant in the open-label phase of the study, and the open-label study focused on the results of the DEX 0.7 mg dose. [Haller.2011]**	Control group/sham therapy (n=426) Dexamethasone implant 0.35 mg (n=414) Dexamethasone 0.7 mg (n=427)	Time to reach a ≥15 letter gain from baseline in BCVA using a standardized ETDRS protocol	Rates of response were numerically slightly higher in the DEX 0.7 mg implant group than in the DEX 0.35 mg implant group, but the difference was not statistically significant. The proportion of eyes achieving at least a 15-letter improvement at day 180 in the 0.7mg group was 22% (92/427), but this was not significantly different from the sham group (18%; 75/426)	Patients treated with 1 or 2 doses of the dexamethasone implant 0.7 mg at a 6-month interval have a favorable safety and tolerably approval at 1 year. [Haller.2011] The IOP increases that developed were transient, moderate, and easily managed. [Haller.2010]	GENEVA showed a reduced treatment burden compared to anti-VEGF treatments, but patients also experienced IOP increases in a proportion of cases and thus require monitoring. The interval of retreatment was 6 months which is unlike real world clinical practice where most patients are treated every 3-4 months. Based on results of the GENEVA studies, the FDA has only approved the 0.7 mg dose of the DEX Implant. [Haller.2011]
SCORE1-BRVO Standard Care vs Corticosteroid for Retinal Vein Occlusion Study	Randomized multicenter study	Grid laser over affected macula (n=137) Triamcinolone 1 mg (n=136) Triamcinolone 4mg (n=138)	The percentage of patients with a ≥15 letter gain from baseline to month 12 in ETDRS letters. [SCORE Study Research Group-BRVO. 2009]	Grid laser: 28.9% Triamcinolone 1 mg: 25.6% Triamcinolone 4 mg: 27.2%	Visual acuity outcomes were similar among the three groups treated, and all groups provided better outcomes than expected compared with no treatment. [SCORE Study Research Group-BRVO.2009] Treatment with triamcinolone 4 mg was associated with higher rates of adverse events than standard care or triamcinolone 1 mg. [SCORE Study Research Group-BRVO.2009]	For patients with BRVO, grid laser should remain the standard of care over steroid. SCORE was the first large, randomized, controlled trial to evaluate intraocular corticosteroids for RVO and led to the investigation of intravitreal dexamethasone implant for this disease.
SCORE1-CRVO Standard Care vs Corticosteroid for Retinal Vein Occlusion Study	Randomized multicenter study	Observation (n=88) Triamcinolone 1 mg (n=92) Triamcinolone 4mg (n=91)	The percentage of patients who gained ≥15 letters from baseline to month 12	Observation: 7% Triamcinolone 1 mg: 27% Triamcinolone 4mg: 26%	Percentage of patients who gained ≥15 letters was consistently lower in the observation arm than in the treatment groups, and the percentage of patients who lost ≥15 letters was consistently greater in the observation group than in the treatment arms.	Intravitreal triamcinolone patients were 5 times more likely than patients under observation to experience a VA letter gain of ≥15 letters at 1 year. [SCORE Study Research Group-CRVO. 2009] However, gains were achieved with frequent retreatment. [SCORE Study Research Group-CRVO.2009]

Clinical Study “Common” Name (formal title)

Study design

Treatment arms

Primary outcomes

Results

Author conclusions

“Real-world” impact

Randomized, prospective, multicenter, masked, sham-controlled, parallel-group phase 3 trials
***NOTE: For the open-label phase, starting 6 months after the initial treatment, the 0.7 mg implant was administered if needed to all patients in any arms. [Haller.2011]

Patients were then followed for an additional 6 months, for a total of 12 months. [Haller. 2011]

A total of 997 study eyes received a DEX implant in the open-label phase of the study, and the open-label study focused on the results of the DEX 0.7 mg dose. [Haller.2011]

Control group/sham therapy (n=426)
Dexamethasone implant 0.35 mg (n=414)
Dexamethasone 0.7 mg (n=427)

Time to reach a ≥15 letter gain from baseline in BCVA using a standardized ETDRS protocol

Rates of response were numerically slightly higher in the DEX 0.7 mg implant group than in the DEX 0.35 mg implant group, but the difference was not statistically significant.
The proportion of eyes achieving at least a 15-letter improvement at day 180 in the 0.7mg group was 22% (92/427), but this was not significantly different from the sham group (18%; 75/426)

Patients treated with 1 or 2 doses of the dexamethasone implant 0.7 mg at a 6-month interval have a favorable safety and tolerably approval at 1 year. [Haller.2011] The IOP increases that developed were transient, moderate, and easily managed. [Haller.2010]

GENEVA showed a reduced treatment burden compared to anti-VEGF treatments, but patients also experienced IOP increases in a proportion of cases and thus require monitoring. The interval of retreatment was 6 months which is unlike real world clinical practice where most patients are treated every 3-4 months.
Based on results of the GENEVA studies, the FDA has only approved the 0.7 mg dose of the DEX Implant. [Haller.2011]

Randomized multicenter study

Grid laser over affected macula (n=137)

Triamcinolone 1 mg (n=136)

Triamcinolone 4mg (n=138)

The percentage of patients with a ≥15 letter gain from baseline to month 12 in ETDRS letters. [SCORE Study Research Group-BRVO. 2009]

Grid laser: 28.9%

Triamcinolone 1 mg: 25.6%

Triamcinolone 4 mg: 27.2%

Visual acuity outcomes were similar among the three groups treated, and all groups provided better outcomes than expected compared with no treatment. [SCORE Study Research Group-BRVO.2009] Treatment with triamcinolone 4 mg was associated with higher rates of adverse events than standard care or triamcinolone 1 mg. [SCORE Study Research Group-BRVO.2009]

For patients with BRVO, grid laser should remain the standard of care over steroid.

SCORE was the first large, randomized, controlled trial to evaluate intraocular corticosteroids for RVO and led to the investigation of intravitreal dexamethasone implant for this disease.

Randomized multicenter study

Observation (n=88)

Triamcinolone 1 mg (n=92)

Triamcinolone 4mg (n=91)

The percentage of patients who gained ≥15 letters from baseline to month 12

Observation: 7%

Triamcinolone 1 mg: 27%

Triamcinolone 4mg: 26%

Percentage of patients who gained ≥15 letters was consistently lower in the observation arm than in the treatment groups, and the percentage of patients who lost ≥15 letters was consistently greater in the observation group than in the treatment arms.

Intravitreal triamcinolone patients were 5 times more likely than patients under observation to experience a VA letter gain of ≥15 letters at 1 year. [SCORE Study Research Group-CRVO. 2009] However, gains were achieved with frequent retreatment. [SCORE Study Research Group-CRVO.2009]